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Has Sarah Nexus been presented to the FDA and what was their response?

The FDA does not endorse individual products and we never expect them to do so, however, they have presented a poster relating to a benchmarking exercise they did of various tools, including Sarah Nexus.

This poster reviews an FDA study, in which they evaluated the performance of two freely-available, open source (Q)SAR programs, Toxtree and OECD Toolbox and three newly-released, commercial (Q)SAR programs, Leadscope Expert Alert System, Sarah Nexus, and Symmetry as potential candidates for qualifying pharmaceutical impurities. To effectively assess their performance, an in-house Salmonella mutagenicity database of 3979 compounds and a highly-curated version of the Hansen dataset of 3700 compounds were used for benchmarking. These sets are comprised of drug-like and industrial chemical examples containing a variety of functional groups as well as less-common atoms. These assessments will improve and facilitate the ability of FDA/CDER to interpret the quality and reliability of in silico data submitted under ICH M7 for the qualification of pharmaceutical.

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